BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022795 · Received March 28, 2008

    Report

    Report Number
    2953144-2008-00219
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED DEVICE FOUND NO MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, THE SUTURE WAS PULLED OUT FROM THE ARTERY. THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE BROKE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. REPORTEDLY, THE SUTURE BROKE WHILE THE KNOT WAS ADVANCED TO THE ARTERIAL SURFACE. A SECOND PERCLOSE PROGLIDE DEVICE WAS USED AND MANUAL COMPRESSION WAS APPLIED FOR FIVE MINS TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PHYSICIAN SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 58013-6H

    Patients

    Seq Age Sex Outcome Treatment
    1